Observational Study With Antiretroviral Treated Patients Switching to Nevirapine Plus Two Nucleoside Reverse Transcriptase Inhibitor (NRTI) Regimens

NCT ID: NCT02191319

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2002-01-31

Brief Summary

Collecting data on maintaining anti-retroviral activity (quantitative HIV RNA determination) and immunological activity (CD4 cells) after switching from protease inhibitor or NNRTI to Nevirapine (Viramune®) and collecting of routinely observed laboratory data on lipids, and liver enzymes.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Viramune®

Patients switching from protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) containing antiretroviral regimen to Viramune®

Viramune®

Intervention Type: DRUG

Interventions

Viramune®

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients suffer from HIV type 1 infection
• Patient is treated with antiretroviral protease-inhibitors or non-nucleoside reverse transcriptase inhibitors
• Patient has shown a depression of viral load before limit of detection (< 50 HIV-RNA copies/ml) for more than 6 months prior to visit 1
• Patient is male or female with age greater than or equal to 18 years
• Women have to be willing to use an effective barrier method of contraception for the duration of the observational study participation

Exclusion Criteria

• Patient has clinically relevant laboratory findings (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > five times upper limit of normal (ULN))
• Patients is hypersensitive to Viramune® or to any of its excipients
• Patient is not able to abstain from treatment with ketoconazole, oral contraceptives, or other drug affecting CYP3A-metabolism
• Patients is breast-feeding
• Patient is pregnant
• Patient is a woman and does not use effective contraception

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1100.1395

Identifier Type: -

Identifier Source: org_study_id